Medical devices clinical investigations
Eurofins C&PC in medical device clinical support
Regulatory compliance
Ensure clinical studies meet EU MDR 2017/745 and ISO 14155:2020 standards, ensuring high quality and patient safety
Qualified investigators and sites
Maintain a database of qualified investigators and sites, including key opinion leaders, to ensure robust and reliable clinical data
Expertise and experience
With 40+ years’ experience, Eurofins has 8 research centers acting as CRO and CRC to support various stages of clinical investigations
Clinical trial management
Offer full-service support: project management, regulatory submissions, data and stats management, and expert medical writing
In-house facilities
Have in-house clinical trial facilities with expertise in medical device investigations, ensuring seamless execution of clinical trials
Ensuring the safety and compliance of cosmetic medical devices is a complex challenge due to stringent regulatory requirements and the need for rigorous testing
Eurofins offers specialized testing services that guarantee compliance with industry regulations, enhance product safety, and support innovation. Our expertise helps you navigate the complexities of medical device testing, ensuring your products meet the highest standards.
What sets Eurofins C&PC apart?
Comprehensive global network
Eurofins operates over 20 state-of-the-art medical device testing facilities across North America, Europe, and Asia Pacific. This extensive network ensures rapid turnaround times and access to a diverse pool of clinical trial participants, facilitating efficient and globally compliant clinical investigations.
Expertise in regulatory compliance
With more than 40 years of experience, Eurofins provides in-depth knowledge of international regulatory requirements. Their laboratories maintain quality systems compliant with cGMP, GLP, and ISO 17025, conducting testing in accordance with ISO, ASTM, ANSI, AAMI standards, as well as custom test methodologies tailored to meet unique customer needs.
Comprehensive testing services
Eurofins offers a full spectrum of testing services, including biocompatibility, microbiology, analytical chemistry, electrical and mechanical testing, packaging validation, and stability studies. This comprehensive approach supports the entire lifecycle of medical device development, from preclinical testing to regulatory submission.
